According to Article 2(44) of the Medical Devices Regulation (EU) 2017/745 (MDR), clinical evaluation is defined as a “systematic and planned process to generate, collect, analyze and evaluate clinical data relating to a device on an ongoing basis in order to verify the safety and performance, including clinical benefits, of the device when used in accordance with the manufacturer’s intended purpose.” Clinical evaluation is therefore the analysis of clinical data required to demonstrate compliance with the General Safety and Performance Requirements (GSPR) of Annex I.
However, in some cases, the use of clinical data may not be appropriate to demonstrate compliance with these general safety and performance requirements: the clinical evaluation may then be based on the Article 61(10) route.
In what cases can Article 61(10) be used? What is the rationale for using this pathway to demonstrate compliance? How do you conduct a clinical evaluation using the Article 61(10) pathway?
The purpose of this newsletter is to answer these questions in order to help you better understand the expectations of Notified Bodies (NBs) in the context of the Article 61(10) clinical evaluation.